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临床试验/NCT01728350
NCT01728350已完成不适用

Improving Well-Being After TBI Through Structured Volunteer Activity

Craig Hospital1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2013年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
1
主要终点
Change from baseline on Satisfaction with Life Scale(SWLS)at post-intervention and follow up points.

研究概览

简要总结

The purpose of this project is to determine if participating in volunteer activity improves the psychological well-being of individuals with traumatic brain injury (TBI).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Has sustained a documented TBI that required inpatient rehabilitation;
  • •is at least one year post TBI;
  • •is age 18 or older;
  • •is able to commit to completing the entire three month volunteer placement;
  • •is English or Spanish speaking;
  • •receives written medical release from a physician to participate in this intervention;
  • •is rated a level 1-2 on the Supervision Rating Scale (functionally independent during the day);
  • •provides informed consent to participate

排除标准

  • •Is employed or engaged in regularly scheduled volunteer work outside of the intervention;
  • •obtains a score of 25 or above on the SWLS, which is 0.5 SD above the TBIMS NDB mean;
  • •unable to travel to assessments and placement; even with study transportation assistance;
  • •has been convicted of a felony, which would prohibit volunteer placement;
  • •unable to communicate effectively to complete standardized assessments;
  • •has cognitive impairment that precludes completion of baseline testing;

研究组 & 干预措施

Treatment

Experimental

Participants in this arm will participate in a novel structured volunteering intervention called HOPE - Helping Others through Purpose and Engagement. This intervention involves orientation, training, volunteer placement assistance, and problem solving and support.

干预措施: HOPE - Helping Others through Purpose and Engagement (Behavioral)

Control

No Intervention

Participants who are randomized to the control arm will be offered the HOPE intervention at the conclusion of study.

结局指标

主要结局

Change from baseline on Satisfaction with Life Scale(SWLS)at post-intervention and follow up points.

时间窗: Baseline, post-intervention, 3 mos f/u, 6 mos f/u

A five-item, self-rated scale of global life satisfaction. Items are rated on 1-7 point Likert scale.

次要结局

  • Change from baseline on Flourishing Scale at post-intervention, and at follow-up points.(Baseline, post-intervetion, 3mos f/u, 6mos f/u)
  • Change from baseline on Brief Symptom Inventory-18(BSI-18)at post-intervention and at follow-up points.(Baseline, post-intervention, 3mos f/u, 6mos f/u)
  • Change from baseline on Scale of Positive and Negative Experience (SPANE)at post intervention and at follow-up points.(Baseline, post-intervention, 3mos f/u, 6mos f/u)
  • Change from baseline on Purpose in Life subscale of RyffScale of Psychological Well-Being at post-intervention and at follow-up points.(Baseline, post-intervention, 3mos f/u, 6mos f/u)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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